Herbalife Criticized at Senate Hearings

Odom Fanning

Opening two days of hearings, Senator William V. Roth, Jr.
(R-DE), chairman of the Senate Permanent Subcommittee on Investigations,
made it clear that their purpose was not to "get" Herbalife
or any other product, but resulted from five months of investigation
into weight reduction products and plans of all types. The Subcommittee
is authorized to investigate the efficiency and economy of all
branches of the government and also has jurisdiction over "all
aspects of crime and lawlessness within the U.S. which have impact
upon or affect the national health, welfare, or safety."

Roth acknowledged that following announcement of the hearings
(held in Washington, D.C., May 14th and 15th), he had received
a "very large number of phone calls and letters from individuals
who are very satisfied with the Herbalife products, and have lost
large amounts of weight." Many of these correspondents, and
an estimated 3,000 Herbalife distributors who marched on the second
day, were obviously on the defensive. So was the Food and Drug
Administration, for, as the senator put it, the purpose of the
hearings was "to find out if the public is being adequately
protected when it buys and consumes diet products."

In his opening remarks, Roth made a distinction between "miracle
pills and creams," tinted sunglasses, plastic ear forms and
other "patently fraudulent products" and the very low
calorie (VLC) products that can actually produce weight loss but
may not be safe. His major concern with the VLC products, he specified,
"is with what the Food and Drug Administration is doing and
what it is not doing, particularly when serious questions have
been raised both within the FDA and outside this agency about
the safety of such products....We are dealing with a multi-billion
dollar industry which produces items ingested into the human body.
Yet the FDA has been reticent to involve itself in low calorie
diets. I want to know why, because I think the public deserves
to know conclusively about the safety of individual products now
in the marketplace."

On the first day Roth's subcommittee heard testimony from scientists
and VLC product users, all of whom submitted written statements
as well. Most of the scientists favored more regulation of such
dietary products; the users were pro and con.

One scientific witness was Judith S. Stern, Sc.D., professor
of nutrition and director of the Food Intake Laboratory at the
University of California, Davis. She conceded:

The inadequacy of traditional medicine to provide a permanent
cure for obesity has given rise to an entire industry of entrepreneurs
who claim to be able to relieve the frustrations of the overweight.
The ironic tragedy is that most diets work-at least initially-when
they are followed. However, fad diets are usually quite restrictive
in their food choices, may have unpleasant side effects, and
most people cannot follow them for any length of time. In addition,
when daily calories are restricted below 1,200, it becomes difficult
to satisfy all other nutrient needs.

Dr. Stern also made the distinction between "miracle cures"
and VLC products. Products in the former category include the
hormone cholecystokinin (CCK), claimed to decrease hunger, and
various amino acid pills, said to release growth hormone. Both
have been promoted with false claims based on legitimate scientific
discoveries that were overgeneralized and misrepresented, she
noted.

Debunking claims that grapefruit or grapefruit extract can
act in a catalytic manner enhancing breakdown of fat, Dr. Stern
described her testimony last year which helped the U.S. Postal
Service stop sales of Super Grapefruit Pills by a California company.
Noting that these pills contained glucomannan, she reported that
in 1980 she had conducted a double-blind study in which the test
group received one gram of glucomannan while the control group
was given a placebo. Both groups were placed on a behavior modification
program. Both groups lost weight, she noted, but there were no
statistically significant differences in hunger ratings or weight
loss between them.

Dr. Stern also zeroed in on kelp/lecithin/cider vinegar/vitamin
B6 combinations found in dietary products since 1974. Iodine-rich
kelp is potentially harmful to a small number of individuals in
whom high amounts of ingested iodine can cause thyroid trouble.
The other three ingredients are worthless, she noted.

Another expert witness was Varro E. Tyler, Ph.D., professor
of pharmacognosy (the science of medicines from natural sources)
and dean of Purdue University's School of Pharmacy and Pharmacal
Sciences. Here is my summary of Dr. Tyler's detailed analysis
of various Herbalife products contained in the lengthy packet
of written material released by Roth's subcommittee to the press:

Slim and Trim Formula #1 (46 cents per day), described
in the sales literature "as a balanced protein powder made
from natural vegetable soy, casein and whey protein." Tyler
said the product is falsely represented in company literature
because there is nothing about a protein powder, per se, that
will curb the appetite any more than an equivalent amount of
protein derived from eating lean meat, nuts, or the like. Further,
no protein powder will "cleanse the system" or facilitate
"burning excess calories." It will supply needed daily
nutrients, but no more effectively than a low-calorie diet, carefully
balanced for carbohydrates, minerals, and vitamins-as well as
protein.

Slim and Trim Formula #2 (21 cents per day), described
by the Herbalife organization as a special blend of 14 herbs
plus kelp, lecithin, vitamin B6, and cider vinegar designed to
cleanse the digestive system and naturally help curb the appetite.
Tyler said that, of its many herbal ingredients, none is actually
present in sufficient quantity to produce significant physiological
effects by itself. But he noted that four ingredients-senna,
cascara sagrada, dandelion root, and kelp-might work together
to exert a laxative effect in sensitive individuals.

Slim and Trim Multivitamin and Multimineral Formula #3
(23 cents per day) is a fairly standard vitamin/mineral preparation
with some herbal products added in such tiny amounts that they
exert no significant effect. Unless vitamin deficiency was present,
Tyler noted, the product would be a complete waste of money.

Slim and Trim Linseed Oil Formula #4 (10 cents per
day) contains small amounts of linseed oil but has no advantage
over less expensive vegetable oils ordinarily used in the kitchen
of the average home. (Moreover, as noted by the next witness,
the amount found in the formula will be obtained in food consumed
in just one balanced meal per day.)

Cell-U-Loss (43 cents per day) is described in Herbalife
literature as a product designed to attack cellulite, promote
circulation, and eliminate excess fluids, is recommended for
use with the Slim and Trim formulas. Tyler noted that its tiny
amounts of herbs would at most cause a slight diuresis (output
of body water), but would have no effect whatsoever on appetite
or body fat.

Herbal-aloe is said to aid digestion and cleanse the
system. Although uncertain of the type of aloe contained in this
product-which may be a laxative-Tyler expressed deep concern
over two of its other herbal ingredients. Comfrey, he said, is
a known carcinogen, shown to produce malignant tumors in the
livers of rats when included in their diet. And the active constituent
of chapparal, nordihydroguaiaretic acid (NDGA), was removed from
the FDA's GRAS (Generally Recognized As Safe) list many years
ago after it was shown to cause cysts and kidney damage in rats.

N.R.G. (Nature's Raw Guarana) (80 43 cents per day),
claimed to increase energy, aid in mental alertness and produce
a nutritional lift, is sold in tablets that contain small amounts
of granular guarana, the seed of a South American plant known
to contain about 5% caffeine. The amount of caffeine in the recommended
dose of N.R.G. is about the same as that in a cup of strong coffee-but
the presence of caffeine is not revealed in product labeling
or literature. Thus, individuals sensitive to caffeine might
be unwittingly harmed.

Schizandra Plus tablets are said to help combat stress
and damage leading to premature aging. Although he suspected
that the dosage of its ingredients was too low to exert pharmacological
effects, Tyler indicated that tests are needed to determine whether
chemicals extracted from schizandra can protect or harm the liver
[see NF 2:29].

Tang Kuei (50 cents per day), said to help establish
menstrual regularity and provide "herbal nutrition"
for the whole body, contains dong quai (also known as dang gui
and pinyan) and chamomile. These drugs -- used in traditional
Chinese medicine -- have not been proved by Western standards.
Tyler noted that even if they are effective, the amounts contained
in Tang Kuei are far below those used in China. Moreover, under
federal law, Schizandra Plus and Tang Kuei are unapproved new
drugs that are not legal to sell in the United States.

Overall, Tyler objected that

Some Herbalife products may well be toxic, at least to some
consumers.

Herbalife literature and word-of-mouth recommendations build
up false hopes in consumers, most of whom are not able to benefit
from the placebo effect.

It is particularly deceptive because they lead the public
to believe that Herbalife products "contain a lot of wonderful
herbs with marvelous health-giving properties when the amounts
present in the products are too small to have any significant
physiological effects in normal persons.

Consumers are thus paying good money for products which have
no proven value.

Many of the same points were reiterated in an analysis of the
various Herbalife formulas by F. Xavier Pi-Sunyer, M.D., associate
professor of Medicine, Columbia University College of Physicians
and Surgeons, and a division chief at St. Luke's Roosevelt Hospital
Center, New York City.

"With very rapid weight loss, and particularly with diets
low in carbohydrate, there is an early diuresis, that is, loss
of water via the urine. This accounts for much of the weight loss
of crash diets and much of this water is reaccumulated when the
diet is stopped," said Dr. Pi-Sunyer. "With this water
loss, great amounts of sodium, potassium, and chloride are lost,
as well as lesser but substantial amounts of calcium, magnesium,
and other minerals. These must be replaced. If they are not, the
electrical integrity of biological membranes may be lost, and
one outcome of this may be cardiac arrhythmias."

Because dieters wish "to get on with it," there may
be a tendency to take only the protein preparation, without supplementing
it, as sometimes recommended, by a meal to bring the daily intake
to at least 800 to 1,000 calories (of which 300 to 400 may be
provided by the dietary product). Consumers also may ignore the
limited period, say four weeks, recommended by some diet purveyors,
and incur added risk by consuming the preparation for a longer
time, said Dr. Pi-Sunyer.

He also reported that a colleague, Theodore B. Van Itallie,
M.D., had reexamined data of the victims of the liquid protein
diets of 1977-1978 and found that "the less fat you are the
more dangerous these diets are for you, the more likely you are
to lose life-requiring protein, and the more at risk of dying
you are. Since these preparations are bought without restriction,
many people take them who are not very fat, and these people seem
to be particularly at risk."

Two of the four laypersons who testified were constituents
of Senator Roth's-one for Herbalife, the other against. Patricia
Stombaugh, of Smyrna, Delaware, began taking Herbalife in August
1984. "After taking it for two months, losing five pounds
and feeling much better," she was asked by friends "for
more information about Herbalife." She soon became a distributor.
She and her representatives since have sold it to over 300 people.
"Herbalife has worked for me and my customers," she
told Roth and the subcommittee. "I believe the people who
said they felt better using the Herbalife products are stating
the facts: their health problems improved through weight loss
and sound nutrition. They are not saying that Herbalife is like
a medicine that cures a disease. No one I know has ever claimed
this."

Another user, Greg Martin, of Dover, Delaware, lost about 13
pounds in three months and "felt better than I had in years,"
after starting on Herbalife products in September 1984. He and
his wife began selling the products in October, eventually building
a customer list of 100 with ten distributors. But most of his
customers suffered from constipation when using Slim and Trim
Formulas, and 10 -15%t had other problems, he reported. One man
who had had two previous heart bypass operations was taking Herbalifeline
because Martin "understood from the literature that it was
good for heart problems. This man became extremely constipated."

Because he was unable to get answers to his questions from
Herbalife headquarters, Martin stopped selling its products to
retail customers at the end of February. "I do not want to
be associated with a company who claims its products are safe
for everyone to use and then will not deal with [health] problems,"
he testified. He expressed the conviction "that diet products
and food supplements can do a lot of good. I would not want to
see them prohibited." He suggested, however, that standards
be established and that the FDA "enforce these standards
so that the public can be confident that these products are safe."

The final two lay witnesses testified to personal tragedies.
Bernard Lehman, of Anaheim, California, formerly from a town near
Nashville, Tennessee, said that he is not able to work because
he has Hodgkin's lymphoma, a form of cancer. A few months ago,
while "basically bedridden," he claimed that a distributor
in Tennessee told him and his wife that she could lose weight
taking Herbalife products, that both could earn needed income,
and that "the Herbalife products would help to cure my cancer."

Lehman named the distributor and charged, "He told us
this orally and showed us some brochures which said this"
in writing. "However, he gave us different brochures without
this information and said that he only had one copy of the special
brochure, and he had to keep it for his use." Lehman summarized
by saying that the distributor "basically said that the Herbalife
products would act as a cure-all."

Although he and his wife had "bad reactions" to the
Herbalife products, they continued taking them "because we
believed that we could make lots of money and we thought our own
bad reactions to taking the products were unusual." They
spent about $1,800 for inventory and publications and sold about
$100 worth of Herbalife products before asking to get out and
get their money back. They eventually received $1,000 from the
distributor and still have $700 worth of product they "would
just like to get rid of...and forget about."

Cynthia Guillaume Lee, of New Orleans, told the pitiful story
of her late husband, Bivian Lewis Lee, Jr., who had retired as
a National Football League player in 1976. He became a Herbalife
distributor in October 1984 because "the extra money sounded
real good," said Mrs. Lee. Although he was not overweight
and "was very much against taking any kind of diet product,"
he began taking a Herbalife product because "he said that
if he was going to sell it, he would at least try it out."

Two weeks later, Bivian, age 35, was dead. His widow testified:

I know that I'm not a doctor. I know that I'm not qualified
to give medical opinions. But I do know that my husband was a
perfectly healthy man. I saw him deteriorate from the perfectly
healthy man to his death. And it all began when he started taking
Herbalife. I want to tell what happened to me-it's not easy for
me to do this-because I want this subcommittee, or the Federal
Food and Drug Administration or somebody to investigate why my
husband was alive and well until he started on the Herbalife
products and now he's dead. I want to encourage the subcommittee
to look into this so that other young mothers won't find themselves
in my position.

Mrs. Lee submitted an affidavit by Dr. Van Itallie, who had
reviewed the autopsy protocol prepared by the Orleans Parish Coroner's
Office and other records relating to Bivian Lee's death. The affidavit
cites an article Van Itallie co-authored, entitled "Cardiac
dysfunction in obese dieters: a potentially lethal complication
of rapid, massive weight loss" [American Journal of Clinical
Nutrition 39:695-702, 1984]. The article discusses the cases of
17 obese but otherwise healthy persons on VLCs who died of cardiac
arrhythmia. "Basically," the affidavit says, "severe
restriction of caloric intake causes the body to ulitize and deplete
its protein. The heart is a muscle, made of protein, and it is
not spared . . . . depletion of protein from the heart may be
followed by cardiac arrhythmia and death. I refer to this as the
'liquid protein syndrome', but it may develop from any drastic
reduction in caloric intake. My thesis further holds that persons
with lesser stores of body fat are more likely to experience the
cardiac dysfunction. Fatter dieters seem to survive longer because
they are better able to conserve their body protein."

Van Itallie found this thesis consistent with Bivian Lee's
case, particularly because he was "persuaded by Lee's Body
Mass Index, indicating that he had lesser stores of body fat."

______________________

This article was published in the September 1985 issue of Nutrition
Forum, when Mr. Fanning edited and published a newsletter
called Con$umer New$weekly. Before that, he was a science
writer for The Atlanta Journal and director of information for
the U.S. Centers for Disease Control and Prevention. Bivian Lee's
lawsuit was settled out of court for an undisclosed sum which
was undoubtedly substantial.